• According to the Wall Street Journal (paywall), the impact of the recent E. coli outbreak in romaine lettuce continues to ripple through the market, causing a 44.5% drop in retail sales of romaine as compared to the previous year and a 27.6% drop in sales of lettuce overall.
  • Retailers, restaurants, and growers are already facing multiple lawsuits arising out of the lettuce recall, which sickened 172 people in 32 states and which resulted in 1 death and 75 hospitalizations.
  • Aside from identifying Yuma, Arizona as the growing area that was the source of the tainted lettuce, FDA has not otherwise identified the primary source of the outbreak.  The lack of traceability has led to discussions as to whether blockchain, a digital ledger system developed originally to verify cryptocurrency transactions, could help with foodborne illness outbreak traceability in the future.
  • FDA has released a Small Entity Compliance Guide (SECG) to help food facilities comply with the registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Section 415 of the FD&C Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA. While the registration requirement has been in effect since 2003, the requirements were revised under the Food Safety and Modernization Act (FSMA).
  • As previously reported on this blog, FDA published a final rule on July 14, 2016, as part of its FSMA implementation strategy that added new provisions to the facility registration requirements. These new provisions included an email address requirement, required assurance that FDA will be permitted to inspect registered facilities, and a revised definition for “retail food establishment.” In an announcement about the SECG, FDA also noted that in addition to the Guide, the Agency also updated its Registration of Food Facilities webpage to include a flowchart to help facilities determine if they are considered a retail food establishment and, therefore, exempt from food facility registration requirements.
  • FDA has previously issued both final and draft guidance documents on the food facility registration requirement since the final rule was published in 2014. These include a guidance that updated the food products categories that companies can select when registering as a food facility (see our September 28, 2016 blog) and several versions of a Draft Q&A Guidance on Food Facility Registration (see our January 3, 2017 blog for information on the most recent update). The Q&A draft guidance contains specific details on the registration process—such as whether using chlorinated water to wash lettuce on a farm is considered processing or whether facilities that operate under USDA FSIS inspection are required to register—however, that guide remains in draft format.
  • The SECG includes information on why facilities must register, details on which facilities must register and which facilities are exempt, an explanation of who is required to register, a discussion of the consequences of not registering, and an explanation of when FDA can suspend a facility registration. It also provides detailed information on how to register a food facility and discusses electronic submissions, which will be required beginning January 4, 2020. (A Federal Register notice on the SECG was published on May 28, 2018.)
  • Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about food facility registration or other FSMA-related requirements.
  • As previously discussed on this blog, the Food Safety Modernization Act (FSMA) established a voluntary, fee-based program for the review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the U.S. Importers are required to meet certain eligibility requirements, such as ensuring that the facilities of their foreign supplier are certified under the Accredited Third-Party Certification Program.
  • On May 25, 2018, FDA released a constituent update encouraging importers to prepare for the next application cycle. While the VQIP application portal opened in January and lasts through May 31, FDA does not anticipate that importers will be able to apply during this application cycle while certification bodies (also known as third-party auditors) receive their accreditation. So far, FDA has recognized two accreditation bodies, ANSI-ASQ National Accreditation Board (ANAB) and the American National Standards Institute (ANSI), to assess and accredit certification bodies. Currently, no certification bodies have been accredited.
  • Because no such certification bodies have yet been accredited, importers are not able to apply to participate in VQIP for the FY19 benefit year. Due to the time needed to accredit certification bodies, FDA is considering an early opening for the FY20 application portal later this calendar year once certification bodies have been accredited. This would allow importers to submit their completed applications early. For importers interested in participating, FDA encourages the following preparation:

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about the VQIP application process.

  • On May 22, 2018 FDA announced that it had issued warning letters to three companies marketing kratom products with medical claims.  FDA’s letter asserts that the claims that the products could be used as pain killers, to reduce opioid dependence, to treat diabetes, to lower blood pressure, and to treat other ailments; are medical claims that have not been reviewed by the Agency.  Such claims, when not approved by FDA, render the products unapproved new drugs.
  • FDA Commissioner Gottlieb indicated that these warning letters are part of a concerted effort to fight the opioid epidemic.  The effort by FDA includes a commitment to “make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies.”  Commissioner Gottlieb encouraged kratom manufacturers to provide FDA a new drug submission if the manufacturers have data that can substantiate medical claims.  Commissioner Gottlieb’s call for submissions specifically noted pain treatment or opioid addiction claims.
  • These warning letters come on the heels of widespread salmonella contamination of kratom containing products, resulting in multiple recalls, a 2016 seizure of kratom products promoted with unapproved drug claims, and FDA’s general emphasis on addressing the opioid crisis.  The actions are also consistent with FDA’s recent crackdown on youth tobacco use, another FDA strategic priority.  It is clear that FDA is taking, and will continue to, take, aggressive steps to pursue its strategic priorities.  For manufacturers, distributors, and retailers of products that might be impacted, increased vigilance to ensure compliance with all regulations and laws impacting the your products is in order.  Those wishing to make medical claims on products will need to determine if such claims will render their product a new drug and take actions (potentially including submitting new drug application to FDA) consistent with this assessment.

The Daily Intake will return on Tuesday, May 29.  We extend our best wishes to those of you celebrating the Memorial Day holiday.

  • The Missouri Senate has passed an omnibus spending bill that adopts SB 977, the state bill that prohibits the marketing of plant-based meat analogs with the term “meat.”  The bill has been passed by the Missouri House and now goes to the governor for signing.  The bill had the support of the Missouri Farm Bureau, Missouri Cattlemen’s Association, and the Missouri Pork Association and was opposed by the Plant Based Foods Association.
  • The Missouri law comes on the heels of a similar law that passed on April 13, 2018 in France (Amendment No. CE2044), which prohibits the use of terms including filet, bacon, or sausage to be used for meatless products.
  • Similarly, Arkansas recently passed a resolution calling for a standard for rice (that would prohibit the marketing of riced cauliflower, for example, as “cauliflower rice”).  At the federal level, the Dairy Pride Act seeks to limit the ability to market non-dairy alternatives to milk with terms like milk, yogurt, and cheese.  These initiatives may mark a trend of increased state and federal activity on standards of identity and naming of foods.
  • On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the companies are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, reduce early skin aging caused by the sun, or protect from the risks of skin cancer.” FDA instructed the companies to correct all violations associated with their products and were advised to review product labeling and websites to ensure that the claims do not violate federal law. Examples of claims include “Enhances photoprotection,” “It’s basically an oral sunscreen,” and “Every second you spend in the sun damages your skin. But Sunsafe Rx is always working: it protects your whole body,” according to the FDA’s letters.
  • In a statement released by FDA Commissioner Scott Gottlieb, M.D., it was made clear that there is no pill or capsule that can replace sunscreen. Commissioner Gottlieb stated that legitimate sunscreens are made in a wide range of sun protection factor values, also known as SPF values, and are over-the-counter drugs that come in many forms. These include lotions, creams, sticks and sprays. All of these formulations are applied topically over the skin and must pass certain tests before they’re sold.
  • FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed. However, FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.
  • The Washington Department of Fish and Wildlife (WDFW) recently rejected Cooke Aquaculture’s request to move 800,000 Atlantic salmon into Puget Sound net pens. WDFW cited two reasons for denying the permit.
    • The Atlantic salmon that would have been transported to the Puget Sound net pens tested positive for a form of the fish virus PRV (piscine orthoreovirus) that occurs at the Iceland hatchery where the company sources salmon eggs. That form of PRV is not known to occur in Puget Sound, so WDFW classifies it as “exotic” in Washington.
    • Cooke proposed to place fish into pens that have not been emptied for at least 30 days after the most recent harvest of adult fish, which would contradict the company’s own management plan.
  • This is not the first setback for Cooke with regards to salmon farming in Washington State. As previously reported on this blog, Washington State passed a bill to phase out Atlantic salmon and other non-native fish farming. Washington Governor Jay Inslee signed that bill (HR 2957 ) on March, 22, 2018. The new law prohibits the state of Washington from issuing any new permits for “activities associated with the use of marine net pens for nonnative marine finfish aquaculture…” Current leases will continue to be honored. Cooke plans to continue to operate its net pens in the state until its leases expire in 2022, reports WDFW.
  • A driving factor in Washington state’s actions concerning farming of Atlantic salmon has been to protect Pacific salmon that is native to the waters around the state. Efforts to ban salmon farming in Washington State began shortly after more than 240,000 Atlantic salmon escaped from a Cooke net pen in August 2017. That net pen was located near Cypress Island in Puget Sound. Shortly after the governor signed HR 2957, Sen. Kevin Ranker (D-Orcas Island), who sponsored the bill stated, “We’ve invested so much in trying to recover our wild pacific salmon populations, there is no sensible purpose for allowing non-native species into the Salish Sea. The day-to-day impact of invasive aquaculture — feces, disease, loose food pellets or lice — could have serious impacts. The state ban is a strong stance to ensure the protection of our marine environment and native salmon populations in the Salish Sea.”

 

  • Three FDA Food Safety Modernization Act (FSMA) rules (Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals) require importers and facilities to evaluate their suppliers’ compliance with food safety laws and the Food and Drug Administration’s (FDA) regulations.  FDA created a Supplier Evaluation Resources page that lists multiple FDA databases that can be searched to determine whether a supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.
  • Last week, a new section was added to FDA’s DATA DASHBOARD to provide a tool for searching multiple databases relevant to supply-chain verification requirements in a single search.  Anyone can search by entering all or part of a firm’s name, or the firm’s FDA Establishment Identifier (FEI).  Results may return several rows, including many with the same name.  Address information can be used to distinguish locations since each company location will display a separate firm profile.
  • We caution, however, that relying solely on the new consolidated search tool to discover relevant information will not likely satisfy importers’ and facilities’ supply-chain verification obligations because the dashboard search encompasses only finalized and completed FDA actions.  In addition, it is also not clear whether the databases are comprehensive.  For example, the bottom of the “results” page from a dashboard search includes a caveat: “Actions pertaining to foreign firms often take the form of import alerts, and are currently not reported in this Dashboard release,” suggesting the new consolidated search tool does not locate import alerts, which are relevant to evaluating a supplier’s performance and the risk associated with a food under the FSVP and the supplier approval process under the Preventive Controls rules.  However, for at least some companies, the search results include Import Alert information under a tab called “Import Alert & Warning Letters.” Regulated companies should use the search tool as one part of their supplier assessment efforts.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about FSMA supply-chain verification requirements.

 

  • As previously discussed in this blog, in November 2013, FDA announced its tentative conclusion that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS).  In June  2015 FDA issued a final determination the PHOs are not GRAS and must be regulated as food additives – which require FDA approval prior to use in food.  As we blogged about further, subsequent to FDA’s determination that PHOs are not GRAS, a leading food industry trade association, the Grocery Manufacturers Association (GMA) filed a food additive petition for certain PHOs present in low levels in foods when used as carriers for color additives and flavoring agents, pan release agents for baked goods, and as processing aids.
  • Today FDA announced that foods manufactured using PHOs before June 18, 2018 may remain on the market until January 1, 2020 to accommodate the shelf life of the products.
  • FDA’s announcement also indicated that it is denying the GMA petition “because the petitioners did not provide sufficient evidence that the requested uses are safe.”  FDA did acknowledge that industry may need additional time to find replacements for the PHOs that were the subject of the petition, so the PHOs that were the subject of the petition have until June 18, 2019 to be removed from manufactured food and foods manufactured before this date have until January 1, 2021 to remain on the market.
  • FDA’s tables summarizing the extended compliance dates is reproduced below:

 

Non-Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with non-petitioned uses of PHOs June 18, 2018 Not extended
Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 June 18, 2018 January 1, 2020
Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with the petitioned uses of PHOs June 18, 2018 June 18, 2019
Foods manufactured with the petitioned uses of PHOs before June 18, 2019 June 18, 2018 January 1, 2021

  • Eight non-profit organizations (Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, Natural Resources Defense Council, and WE ACT for Environmental Justice) are suing FDA to seek a prohibition on the use of various flavors in food.  The lawsuit is the latest non-profit effort to compel FDA action after the Agency has not acted on a citizen petition.  In this case, a citizen petition was filed in 2016 requesting that FDA amend its regulations to no longer authorize the use of the same synthetic flavoring food additives and to establish zero tolerances for the additives.
  • The seven flavors at issue, which are cleared under 21 CFR 172.515 (“Synthetic flavoring substances and adjuvants”), are benzophenone (also known as diphenylketone), ethyl acrylate, eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol), myrcene (also known as 7-methyl-3-methylene-1,6-octadiene), pulegone (also known as p-menth-4(8)-en-3-one), pyridine, and styrene.  The complaint, filed in the U.S. Court of Appeals for the Ninth Circuit, alleges that these substances cannot be added to food because they are carcinogens under the Delaney Clause, as set out in Section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act.
  • The Styrene Information and Research Center (SIRC)  has submitted a petition to FDA, requesting that the Section 172.515 listing for styrene be removed because its use as a flavoring has been permanently abandoned.  It will be interesting to see whether additional abandonment petitions are filed for any of the other six flavors targeted in the suit.